Clinical research response to the monkeypox public health emergency of international concern

Since early May 2022, an outbreak of monkeypox is spreading around the world, with almost 53,000 laboratory-confirmed cases reported. According to the European Centre for Disease Prevention and Control (ECDC), as of 20 September 2022, 19,827 confirmed cases of monkeypox have been reported from 29 EU/EEA countries. On 23 July, the WHO Director-General declared this outbreak to be a public health emergency of international concern. Following this declaration, and in agreement with the Member States, additional Horizon Europe funds are being mobilised to support urgent clinical research on monkeypox.

The Horizon 2020 project EU RESPONSE (GA 101015736) is, as part of its grant agreement obligations, already undertaking research closely linked to EU research needs for the monkeypox public health emergency.

Further, reacting swiftly to set up the clinical research response to the monkeypox outbreak at an early stage, the EU RESPONSE consortium has shown much appreciated leadership, in line with the grant agreement. The consortium mobilised its established network while also engaging with other European partners such as Ecraid, as well as international partners such as the World Health Organization and the Institut National pour la Recherche Biomedicale in the Democratic Republic of Congo, where monkeypox is endemic.

In this context, the EU RESPONSE consortium is uniquely-placed to support pertinent research efforts to confront the public health emergency, in a quick and efficient manner considering the exceptional circumstances.

The proposal should be focused on the monkeypox clinical research response, building on the existing consortium of the EU RESPONSE project and allowing for new partners, as relevant for the specific monkeypox outbreak context.

The scope of the proposal should be the conduct of clinical trials for monkeypox therapeutics to support better treatment of monkeypox disease and further inform public health policy and clinical management, and in particular encompass both the MOSAIC and EPOXI trials, as well as anticipate the necessary support for the trial coordination board (TCB). It is expected that quality-controlled data are shared in accordance with the FAIR principles[[FAIR data are data which meet principles of findability, accessibility, interoperability, and reusability. Data can include exploitation of information and data from European data infrastructures and programmes such as Copernicus, European Space Agency and the GEO initiative. For further details, see the FAIR principles website (https://www.go-fair.org/fair-principles), the FAIR cookbook (https://faircookbook.elixir-europe.org/content/home.html) and the guides for researchers on how to make your data FAIR (https://www.openaire.eu/how-to-make-your-data-fair).]]. The use of harmonised protocols in collaboration with other actors, such as the World Health Organization, is recommended for this purpose. The proposal should take into account the geographic dynamics of the epidemic and anticipate the current decline of cases in the EU/EEA.

Taking into account the context of a public health emergency of international concern, the proposal can be succinct.

The details of clinical studies should be provided in the dedicated annex using the template available in the submission system. A clinical study covers clinical studies/trials/investigations/cohorts and is defined as any systematic prospective or retrospective collection and analysis of health data obtained from individual patients or healthy persons in order to address scientific questions related to the understanding, prevention, diagnosis, monitoring or treatment of a disease, mental illness, or physical condition. It includes but it is not limited to clinical studies as defined by Regulation 536/2014 (on medicinal products), clinical investigation and clinical evaluation as defined by Regulation 2017/745 (on medical devices), performance study and performance evaluation as defined by Regulation 2017/746 (on in vitro diagnostic medical devices).

In accordance with General Annex G, it is recalled that a starting date before the date the grant is signed (retroactive) can be granted exceptionally for duly justified reasons. Since the monkeypox outbreak was declared a public health emergency of international concern on 23 July 2022, a retroactive starting date may be considered if properly justified in the application, also taking into account that early intervention by the Union is of major importance. Costs incurred from the starting date of the action may be considered eligible.